ISRCTN92946117.
| Trial name or title | The FINOF ‐ Femoral nerve‐block Intervention in Neck Of Femur fracture study Approved by Nottingham Research Ethics Committee 2, 28th January 2011, ref: 10/H0408/113 Funding: governmental; Funder name: National Institute of Health Research (NIHR) (UK) ‐ Research for Patient Benefit (RfPB) |
| Methods | RCT |
| Participants | 150 elderly patients admitted with an acute hip fracture Inclusion criteria: aged ≥ 70 years, resident in their own home or warden‐aided flat, cognitively intact (as defined by a score ≥ 7 on the Abbreviated 10 point Mental Test Score (AMTS), and prior fracture New Mobility Score ≥ 3 (indicating independent indoor ambulation) Exclusion criteria: prefracture hospitalization, contraindications to femoral nerve block analgesia, regular pre‐fracture opioid or glucocorticoid therapy, alcohol or substance abuse, morphine intolerance, postoperative surgical restrictions for ambulation |
| Interventions |
Treatment group: femoral nerve block followed by continuous infusion Control group: standard analgesic care |
| Outcomes | Drug‐related adverse events, earlier recovery, shorter length of stay in hospital and overall, improved quality of life for patients suffering with an acute hip fracture Primary outcome measures: cumulative dynamic pain score, cumulative ambulation score measured from day 1 to day 3 postoperatively Secondary outcome measures: cumulative dynamic pain score preoperatively (at 30 minutes, 60 minutes, 12 hours after initial femoral nerve block), cumulative side effects (nausea, vomiting, constipation, delirium) (from admission to day 3 postoperatively), cumulative calorific and protein intake (from admission to day 3 postoperatively), health‐related quality of life measured on the EUROQOL EQ‐5D, informing a cost‐effectiveness analysis, hospital length of stay, rehabilitation outcome measured by New Mobility Score, participant and staff experience (qualitative study) |
| Starting date | 02/01/2012 |
| Contact information | Dr Opinder Sahota, Queens Medical Centre, Derby Road, Nottingham, NG7 2UH, United Kingdom; opinder.sahota@nuh.nhs.uk |
| Notes | Completed: DOI 10.1186/ISRCTN92946117 EudraCT number: 2010‐023871‐25 http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=10929 http://www.nuh.nhs.uk/ http://www.ncbi.nlm.nih.gov/pubmed/24885267
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